BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA

    MDR report key: 3033334 · Received April 3, 2013

    Report

    Report Number
    1823260-2013-02015
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER THAT THE AVIVA METER CAUGHT ON FIRE BY ITSELF. SHE DID NOT ALLEGE THAT ANYTHING CAUSED THE METER TO CATCH FIRE OR THAT IT WAS EXPOSED TO ANYTHING THAT COULD CAUSE FIRE. IT WAS STORED AS NORMAL AND KEPT IN THE HOUSE. SHE STATED THAT THERE WERE SOME FLAMES AND THAT THE METER SCREEN APPEARED TO BURN UP AND TURN WHITE AND BLACK. METER THEN WAS SMOKING. A REQUEST WAS MADE FOR THE RETURN OF THE METER, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136038 ACCU-CHEK ® AVIVA BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1